Argen Corporation

Compliance

• Maintains Regulatory Affairs certifications for domestic and international customers and distributors.
• Ensures Argen uses relevant information and judgement to determine whether events or processes comply with laws, regulations, or standards.
• Reviews document changes, product labeling and in-house procedures to ensure regulatory requirements are met.
• Prepares for and facilitates internal, external, and third-party audits as necessary.
• Provides input for selecting the most effective regulatory course of action.
• Supports International Operations with foreign product registration through distributors according to each country’s regulatory requirements.
• Researches and responds to internal and external customer requests for regulatory information.
• Interprets regulatory rules or rule changes and ensures that they are communicated through corporate policies and procedures.
• Interfaces with the FDA concerning issuing Certificates to Foreign Government for The Argen Corporation and its subsidiaries as needed.
• Maintains Quality Assurance and Quality Management Certificates (ISO and CE) for The Argen Corporation and its subsidiaries interfacing with Notified Bodies.
• Maintains Declaration of Conformities for all Argen products and its subsidiaries.
• Reviews product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
• Accurately maintains the regulatory database to reflect all current and obsolete products.
• Communicates with the Secretary of State office, Department of State and Foreign Embassies or Consulates regarding authentication of documents to support the registration process.
• Supports product registration for Argen’s International Branches to meet foreign requirements for China, Canada, Taiwan, Korea, and others.
• Develops and generates customer-specific certificates of quality analysis and conformities to satisfy distributor and customer-specific needs.
• Completes supplier and subcontractor evaluations and approval forms for customers.
• Provides and submits regulatory documentation to notified bodies and Authorized Representative to support MDD/MDR requirements.
• Represents Regulatory Affairs and Quality team in yearly audits for quality and regulatory documentation including Technical Documentation.
• Contributes to Regulatory projects and deliverables to ensure Argen remains compliant to MDR and ISO requirements.

Regulatory Affairs Specialist

Field Engineer

• Installs and configures digital dental laboratory equipment at customer sites
• Ensures all systems and software products are properly set up and calibrated
• Provides initial training to customers on equipment operations and maintenance
• Performs routine maintenance on digital dental equipment to ensure optimal performance
• Diagnoses and repairs technical issues, both remotely and on-site
• Replaces and/or repairs faulty components and ensures equipment is restored to proper working condition
• Responds to customer inquiries and provides technical assistance via phone, email, and on-site visits
• Performs troubleshooting duties for software and hardware issues, offering effective solutions
• Maintains detailed records of service calls, repairs, and maintenance activities
• Educates customers on best practices for equipment usage and maintenance according to manufacturer’s specifications and guidelines
• Provides ongoing training sessions to ensure customers are proficient in using the equipment
• Develops and distributes instructional materials and documentation to customers as requested
• Ensures all service activities comply with company quality standards and regulatory requirements
• Conducts equipment performance checks and validates repairs to ensure functionality
• Monitors and reports on equipment performance trends and potential issues
• Works closely with the internal support teams to address customer needs and improve service delivery processes
• Communicates effectively with customers to keep them informed about service activities and repair status
• Collaborates with internal support teams to develop solutions for complex technical issues

Field Service Technician

Supply Chain

• Tracks, reviews, and monitors all incoming material and supplies used in production or resale products.
• Ensures compliance to the appropriate standards.
• Conducts cycle counts and accurately inputs results into the QAD system.
• Ensures area cleanliness and proper product organization, including consolidation of items and lot numbers.
• Completes daily cycle count sheets and promptly reports any discrepancies or variances to supervisory personnel.
• Releases materials to internal departments according to established processes.
• Responds to and fulfills material requests from internal departments efficiently.
• Accurately records inventory movements and transactions in the QAD system, identifying and addressing any variances.
• Reviews and verifies the accuracy of recorded transactions.
• Maintains a clean and safe work environment in alignment with safety regulations and standards.
• Cross-trains across multiple areas to enhance operational flexibility and support team objectives.
• Reports issues, concerns, or discrepancies to the Lead, Supervisor, or Manager in a timely and professional manner.

Regulatory Affairs Specialist

Field Service Technician

Inventory Control Clerk I